The Cortisol Levels During Cardiac Surgery. The Comparison Between Etomidate and Thiopentone

Coronary Artery Disease Clinical Trial

Official title:

The Changes in Cortisol Levels and Stress Responses During Cardiac Surgery. The Comparison Between Two Induction Agents: Etomidate and Thiopentone.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495949
• Other study ID #: Si559/2011
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2011
• Last updated: May 21, 2014
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

During induction for cardiac surgery, patient hemodynamic stability is achieved by using anesthetic drugs which least affects hemodynamics such as benzodiazepines, etomidate. Etomidate although has been used for a long time but its safety regarding cortisol synthesis suppression is still doubtful. This study measures the changes in cortisol levels during cardiac surgery with the use of cardiopulmonary bypass by comparison between two inductive agents (etomidate and thiopentone). Recording data also include hemodynamic changes during induction, inotropic use for coming of cardiopulmonary bypass, blood glucose levels, amount of insulin usage, length of ICU and hospital saty.

Description:

Ninety-two cardiac patients who undergoing cardiopulmonary bypass graft (CABG) or valve surgery will be enrolled in this study. They will be randomized into two groups (thiopentone and etomidate groups). Apart from different in two inductive drugs, other anesthetics will be the same. We record hemodynamic changes during inductions, inotropic use (dose and duration), blood glucose levels, total insulin requirement to keep blood glucose 140-180 mg% in perioperative period, duration of mechanical ventilation, length of stay in ICU and total hospital length of stay. The changes in cortisol levels will be recorded at time 0 (before induction), 2, 4, 8, 24 hours in 26 patients (13 patients in each group and only patients who are the first in the operating list (morning list)).The 26 patients is needed from sample size equation for the changes in cortisol level and the 92 patients is calculated from the differences in inotropic use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

60 year or older cardiac patient undergoing cardiac surgery (CABG or valve surgery) with the use of cardiopulmonary bypass -

Exclusion Criteria:

• Redo or emergency operation

• complex and prolong operation

• history of adrenal insufficiency or steroid use

• already has inotropic drugs to support hemodynamics

• creatinine > 2.0 mg/dl

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Valve Diseases
• Myocardial Ischemia
• Valvular Heart Disease

Intervention

Drug:
• etomidate
During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 2-4 mg (1-2 ml) of etomidate will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious.
• thiopentone
During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 25-50 mg (1-2 ml) of thiopentone will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious

Locations

Country	Name	City	State
Thailand	Siriraj Hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cortisol levels	Measure cortisol levels and its changes due to stress response during surgery. Compare the changes in cortisol levels between two induction agents (etomidate and thiopentone).	baseline (before induction), 2, 4, 8, and 24 hrs	Yes
Secondary	the use of inotropes for maintaining hemodynamic	The dose and duration of inotropic drug (S) used for maintaining hemodynamic during coming off cardiopulmonary bypass and postoperative period.	24 hours	Yes
Secondary	Length of ICU and hospital stay		30 days	No